Vaxcyte

PCVX

Market cap $6.35B

The CTO sold 9,743 shares. The sale represented 28.9% of Dhaliwal's holdings.

Vaxcyte keeps its place among Mizuho Securities top picks entering 2026.

Vaxcyte is positioned to disrupt the pneumococcal vaccine market with its engineered VAX-31, overcoming carrier suppression limitations faced by incumbents. PCVX's $2.7B cash position supports an aggressive Phase 3 program, with a projected runway through 2028, mitigating financing and execution risks. VAX-31 targets 95% of U.S. adult IPD strains, aiming for best-in-class breadth and efficacy, with pivotal Phase 3 OPUS trial data expected in Q4 2026.

Trial Design Finalized in Consultation and Alignment with U.S. Food and Drug Administration  Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines Through Head-to-Head Safety, Tolerability and Immunogenicity Comparisons of VAX-31 with Capvaxive (PCV21) and Prevnar 20 (PCV20), the Current Standards of Care Company Expects to Report Topline Safety, Tolerability and Immunogenicity Data for OPUS Phase 3, Noninferiority Trial in the Fourth Quarter of 2026 and Initiate Additional Phase 3 Studies in 2026 with Readouts in 2027, Supporting Planned BLA Submission VAX-31 is Designed to Cover ~95% of Invasive Pneumococcal Disease (IPD) and ~88% of Pneumococcal Pneumonia in U.S. Adults Aged 50+, with Potential to Provide an Incremental 14-34% Broader IPD Coverage and 19-31% Broader Pneumonia Coverage than Standard-of-Care Vaccines VAX-31 Aims to Advance Adult Pneumococcal Protection by Maintaining Critical Pressure on Both Currently Circulating and Long-Established, Historically Disease-Causing Serotypes, While Maintaining or Improving Immune Responses SAN CARLOS, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced that the first participants were dosed in the OPUS (OPA-based Pivotal U.S. Study) Phase 3 pivotal, noninferiority trial evaluating VAX-31 for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults.

Final Data from VAX-24 Infant Phase 2 Dose-Finding Study Consistent with Previously Reported Positive Interim Data; Provide Additional Evidence Supporting Higher VAX-31 Doses Being Evaluated in Ongoing Infant Phase 2 Study

New Agreement with Thermo Fisher Scientific Expands Domestic Capacity to Support Future Commercial Manufacturing of Vaxcyte's Broad-Spectrum Pneumococcal Conjugate Vaccine Candidates

Vaxcyte, Inc. (NASDAQ:PCVX ) Cantor Global Healthcare Conference 2025 September 3, 2025 2:45 PM EDT Company Participants Grant Pickering - Co-Founder, CEO & Director Andrew Guggenhime - President & CFO James Wassil - Executive VP & COO Conference Call Participants Carter Gould - Cantor Fitzgerald & Co., Research Division Presentation Carter Gould Research Analyst Okay. Good afternoon.

VAX-31 Optimized Dose, with Majority of Serotypes Dosed at 4.4mcg and Balance at 3.3mcg, is Designed to Elicit Even Stronger Immune Responses in Infant Population to Protect Against Invasive Pneumococcal Disease (IPD)

Vaxcyte (PCVX) Q2 Loss Widens 11%

Following Interactions with FDA on VAX-31 Adult Program, Including End-of-Phase 2 Meeting, Company Finalizing Phase 3 Clinical Program to Validate VAX-31 as Potential New Standard-of-Care Adult PCV ; Pivotal, Non-Inferiority Study Expected to be Initiated in Fourth Quarter of 2025 with Topline Data in 2026 FDA Provided Input on VAX-31 Adult CMC Licensure Requirements Facilitating Progression to Phase 3; Company Plans to Seek Ongoing Input as Program Advances Company Expects Multiple VAX-31 Adult Phase 3 Program Data Readouts in 2026 and 2027 to Support Biologics License Application Submission For VAX-31 Pediatric Program, Company Modifies Ongoing Infant Phase 2 Dose-Finding Study to Add a VAX-31 Optimized Dose Arm (4.4mcg/3.3mcg) and Discontinues Enrollment of Low Dose Arm; Enrollment in Modified Study Expected to Proceed by End of Third Quarter of 2025 with Topline Data from Both Primary Immunization Series and Booster Dose by End of First Half of 2027 Company Remains Focused on Disciplined Capital Allocation; Streamlining Early-Stage Pipeline to Prioritize Resources for PCV Programs and Further Extend Cash Runway Approximately $2.8 Billion in Cash, Cash Equivalents and Investments as of June 30, 2025 SAN CARLOS, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a business update, highlighting key clinical and regulatory progress for VAX-31, a potential best-in-class pneumococcal conjugate vaccine (PCV).